The Production/Nuclear Pharmacy Manager is responsible for leading all aspects of PET radiopharmaceutical manufacturing and pharmacy operations to ensure the safe, compliant, and efficient production and delivery of critical diagnostic products.

This position provides operational, regulatory, financial, quality, and people leadership while maintaining compliance with current Good Manufacturing Practices (cGMP), radiation safety requirements, pharmacy regulations, and Siemens Healthineers quality standards.

The successful candidate will build and lead a high-performing team, drive operational excellence, maintain inspection readiness, and ensure patients receive life-changing radiopharmaceutical products every day.

**Please note: This position primarily supports overnight production operations. Flexibility to work alternate shifts, weekends, holidays, and on-call schedules is required based on business needs.**

Key Responsibilities

Operational Leadership

• Lead daily operations of the PET radiopharmaceutical production facility and pharmacy.
• Oversee radionuclide production, radiopharmaceutical manufacturing, quality control, dispensing, and distribution activities.
• Ensure timely, accurate, and compliant production and delivery of customer orders.
• Manage inventory levels, production planning, and resource allocation.
• Monitor operational performance and implement process improvements to enhance productivity, quality, and efficiency.
• Ensure the facility maintains a clean, organized, and safe work environment.

Quality & Regulatory Compliance

• Ensure compliance with all applicable federal, state, and local regulations, including cGMP, radiation safety requirements, pharmacy regulations, licensing commitments, and Siemens Healthineers policies.
• Lead site inspection readiness activities and support regulatory inspections and audits.
• Oversee investigations, deviations, CAPAs, change controls, and quality system activities.
• Maintain compliance with all documentation, recordkeeping, and data integrity requirements.
• Ensure proper performance of aseptic processing, sterility testing, endotoxin testing, and quality control procedures.

People Leadership

• Lead, coach, and develop a team of exempt and non-exempt employees.
• Manage recruiting, hiring, onboarding, training, scheduling, performance management, and employee development activities.
• Foster a culture of accountability, collaboration, safety, quality, and continuous improvement.
• Ensure employees maintain required qualifications, certifications, and training requirements.

Financial & Business Management

• Manage site financial performance including operating budgets, resource planning, cost controls, and P&L accountability.
• Establish and monitor site performance metrics and operational goals.
• Support business planning initiatives and continuous improvement efforts.
• Collaborate with regional leadership and cross-functional partners to achieve organizational objectives.

Customer & Stakeholder Management

• Provide exceptional customer support through proactive communication and issue resolution.
• Support customer visits, audits, and relationship management activities.
• Partner with Quality, Regulatory, Operations, Supply Chain, and Commercial teams to ensure customer satisfaction and business continuity.

Technical Oversight

• Manage or delegate operation and maintenance activities for cyclotrons, synthesis modules, analytical instrumentation, QC equipment, and associated software systems.
• Oversee preparation and shipment of radioactive materials in accordance with applicable regulations and company procedures.

Required Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, Health Sciences, or a related scientific discipline.
• Minimum 5 years of experience in pharmaceutical manufacturing, radiopharmaceutical production, biotechnology, healthcare manufacturing, laboratory production, nuclear pharmacy, or another highly regulated environment.
• Minimum 3 years of leadership or supervisory experience managing production, laboratory, pharmacy, manufacturing, or operations teams.
• Demonstrated experience working within a cGMP-regulated environment.
• Experience leading quality, compliance, safety, and continuous improvement initiatives.
• Experience managing employee performance, workforce planning, training, and scheduling.
• Knowledge of regulated manufacturing environments, quality systems, investigations, deviations, and corrective actions.
• Strong analytical, problem-solving, organizational, and decision-making skills.
• Excellent communication and interpersonal skills with the ability to effectively interact with customers, regulators, and cross-functional partners.
• Proficiency with Microsoft Office applications and computerized business or manufacturing systems.
• Ability to work overnight, weekend, holiday, on-call, and alternative shift schedules as business needs require.
• Ability to obtain and maintain all required site-specific safety, regulatory, and operational qualifications.
• Ability to lift, push, pull, and move materials weighing up to 100 pounds, with or without reasonable accommodation.

Preferred Qualifications

• PharmD, Bachelor of Science in Pharmacy, Master's degree, or other advanced scientific degree.
• Nuclear pharmacy experience.
• PET radiopharmaceutical manufacturing experience.
• Active pharmacist license or eligibility for pharmacist licensure.
• Experience serving as Pharmacist-in-Charge (PIC).
• Authorized User (AU) designation and/or experience supporting radioactive materials licensing and radiation safety programs.
• Experience leading FDA, State Board of Pharmacy, NRC, Agreement State, or other regulatory inspections.
• Experience managing multiple exempt and non-exempt employees across multiple shifts.
• Knowledge of cyclotron operations, radiochemistry, and analytical instrumentation.
• Lean Manufacturing, Six Sigma, or continuous improvement certification and experience.
• Direct responsibility for site P&L, budgeting, and operational performance metrics.

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The base pay range for this position is:

$134,300 - $184,668

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.